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Terminated

ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size Selection Large, Cat #901015, UPC 0 51131019985 9

FDA Recall Z-0552-2018 · Posted None

Recalling Firm3M Company - Health Care Business
Recall StatusTerminated
Product CodeNOC
Date Initiated2017-11-01
Date Terminated2020-07-22
Product Quantity996 units

Reason for Recall

Mold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus.

Firm Action

The firm initiated their recall on 11/01/2017 by letter. The letter requested the consignee cease distribution of the recalled product, isolate it pending return. Distributors were asked to notify their customers including a copy of the 3M recall notice.

Root Cause

Packaging process control

Distribution Pattern

AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MO, MS, NC, NH, NY, OH, OR, PA, SC, TN, TX, UT, VA, WI, WV

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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